System and method for determining patient follow-up subsequent to an orthopedic procedure

ABSTRACT

A method of determining patient follow-up subsequent to an orthopaedic procedure includes determining the number of cycles of use of an orthopaedic joint of the patient. If a predetermined threshold is exceeded, communication with an orthopaedic care provider is initiated. A patient monitoring system is also disclosed.

CROSS-REFERENCE TO RELATED U.S. PATENT APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 14/223,393, filed Mar. 24, 2014, which is adivisional application of U.S. patent application Ser. No. 13/300,535,now U.S. Pat. No. 8,702,799, which was filed on Nov. 18, 2011 and was acontinuation application of U.S. application Ser. No. 11/024,888entitled “SYSTEM AND METHOD FOR DETERMINING PATIENT FOLLOW-UP SUBSEQUENTTO AN ORTHOPAEDIC PROCEDURE” by Mark D. DiSilvestro et al., which wasfiled on Dec. 29, 2004, the entirety of which is hereby incorporated byreference.

FIELD OF DISCLOSURE

The present disclosure relates generally to systems and methods for usein conjunction with orthopaedic procedures.

BACKGROUND

Currently, patient follow-up subsequent to an orthopaedic procedure is afunction of the time that has elapsed since the procedure. Indeed,follow-up meetings with the orthopaedic care provider (e.g., thesurgeon) are typically scheduled for dates in the future which reflectthe passage of a given amount of time since the procedure.

SUMMARY

According to one aspect, a system for monitoring a patient's use of anorthopaedic joint which includes first and second joint prosthesiscomponents includes an implantable sensor, a processor, and a memorydevice. The implantable sensor, when implanted in a patient, can be usedto monitor the number of cycles of use of the orthopaedic joint. Theprocessor in communication with the sensor. The memory device iselectrically coupled to the processor and has stored therein a pluralityof instructions which, when executed by the processor, cause theprocessor to (i) monitor output from the sensor to determine the numberof cycles of use of the orthopaedic joint and (ii) to generate a messageto the patient indicative of a need to initiate communication with anorthopaedic care provider if the number of cycles of use of theorthopaedic joint exceeds a predetermine threshold value. In someembodiments, the implantable sensor may be embodied as a permanentmagnet embedded in the first joint prosthesis component and a Halleffect switch embedded in the second joint prosthesis component. Thesystem may further comprising electronics associated with the permanentmagnet and the Hall effect switch that are adapted to determine thenumber of occasions in which the first and second joint prosthesiscomponent are in a predetermined position relative to one another.

In some embodiments, the processor and memory device are embedded in oneof the first and second joint prostheses. Alternatively, the processorand memory device may be located in a data interpretation deviceseparate from the orthopaedic joint. In such embodiments, theelectronics may include a transmitter to transmit data indicative of thenumber of occasions in which the first and second joint prosthesiscomponent are in the predetermined position relative to one another tothe data interpretation device. Additionally or alternatively, theelectronics may be configured to determine the number of occasions inwhich a predetermined angle of flexion is attained by the orthopaedicjoint. For example, the predetermined angle of flexion is indicative ofa step having been taken by the patient. In some embodiments, themessage may be at least one of an audible message and a visual message.

According to another aspect, a system for determining patient follow-upsubsequent to an orthopaedic procedure may include an orthopaedicprosthesis and a computing device. The orthopaedic prosthesis mayinclude a femoral component having a signal source embedded therein anda tibial component having an electrical circuit embedded therein. Theelectrical circuit may include a sensor to generate a data signal inresponse to the signal source. Additionally, the electrical circuit maybe configured to (i) determine the number of occasions in which thefemoral component and the tibial component are in a predeterminedposition relative to one another as a function of the data signal, (ii)calculate a cycle count indicative of a cumulative number of cycles ofuse of the orthopaedic prosthesis, and (iii) transmit the cycle count.The computing device may be configured to receive the data signal andgenerate a message indicating a need to initiate communication with anorthopaedic care provider in response to the cycle count exceeding areference threshold value.

In some embodiments, the signal source may be embodied as a permanentmagnet and the sensor may be embodied as a Hall effect switch.Additionally or alternatively, the computing device may include adisplay. In such embodiments, the message comprises a visual messagedisplayed on the display of the computing device. In some embodiments,the computing device may be further configured to initiate acommunication with the orthopaedic care provider in response to thecycle count exceeding the reference threshold value. For example, thecomputing device may be configured to generate an e-mail to theorthopaedic care provider. Additionally or alternatively, the computingdevice may be configured to initiate a telephone call to an office ofthe orthopaedic care provider.

In some embodiments, the computing device may include communicationcircuitry, a display, a processor, and a memory. The memory may havestored therein a plurality of instructions that, in response to theprocessor, cause the processor to generate a visual message to thepatient on the display that indicates a need to initiate communicationwith the orthopaedic care provider in response to the cycle countexceeding the reference threshold value and initiate a communicationwith the orthopaedic care provider in response to the cycle countexceeding the reference threshold value.

According to a further aspect, a method for determining patientfollow-up subsequent to an orthopedic procedure may include generating adata signal with a Hall effect switch embedded in a first jointcomponent of an implanted joint prosthesis in response to a permanentmagnet embedded in a second joint component of the implanted jointprosthesis. the method may also include generating a cycle countindicative of the number of occasions in which the first and secondjoint components are in a pre-determined position relative to oneanother. Additionally, the method may include transmitting the cyclecount to a computing device external to the patient, comparing the cyclecount to a reference threshold, and initiating communication with anorthopaedic care provider in response the cycle count having apredetermined relationship with the reference threshold.

In some embodiments, the method may include generating an e-mail to theorthopaedic care provider and/or initiating a telephone call to anoffice of the orthopaedic care provider. Additionally, in someembodiments, the method may include generating a message on thecomputing device indicating a need to initiate communication with theorthopaedic care provider in response to the cycle count having thepredetermined relationship with the reference threshold value. Themethod may also include electronically querying the implanted jointprosthesis with the computing device to obtain the cycle count.Additionally or alternatively, the method may include transmitting thecycle count comprises transmitting the cycle count to the computingdevice in response to a query received from the computing device.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a diagrammatic view showing a joint use measurement device inthe form of a pedometer being utilized to determine the cycles of use ofa knee endoprosthesis system;

FIG. 2 is a diagrammatic view showing a joint use measurement device inthe form of a electronic body monitor being utilized to determine thecycles of use of a knee endoprosthesis system;

FIG. 3 is a diagrammatic view showing a joint use measurement device inthe form of an implantable joint cycle counter being utilized todetermine the cycles of use of a knee endoprosthesis system; and

FIG. 4 is a diagrammatic view showing a joint use measurement device incommunication with a communication device.

DETAILED DESCRIPTION OF THE DRAWINGS

The present disclosure relates to a method for determining patientfollow-up after an orthopaedic procedure, such as a joint replacementprocedure, based on the actual use of the patient's joint. As will bedescribed herein in greater detail, the number of cycles of use of thepatient's joint may be determined, for example, by (i) determiningnumber of steps taken by the patient, (ii) determining the activitylevel of the patient, (iii) determining the number of times apredetermined joint flexion angle is achieved, or (iv) determining thenumber of loading cycles of the joint. Determination of these parametersmay be achieved in a number of different manners. When it is determinedthat the patient has achieved a level of use in which follow-up isdesired, a communication with the orthopaedic care provider (e.g., asurgeon, hospital, nurse, primary care provider, or other individualinvolved in the care of the patient) is initiated by notifying thepatient and/or the orthopaedic care provider. As will be describedherein in greater detail, such communication may be achieved in avariety of different manners.

Referring now to FIG. 1, there is shown one implementation of theconcepts of the present disclosure. In this case, a joint usemeasurement device 10 is utilized to determine the number of cycles ofuse of a prosthetic orthopaedic joint 12. In the exemplary arrangementof FIG. 1, the orthopaedic joint 12 is exemplary embodied as a kneeendoprosthesis system 14 for use in a total knee replacement procedure.The knee endoprosthesis system 14 is implanted on the distal end of thefemur 16 and the proximal end of the tibia 18. The endoprosthesis system10 includes a tibial bearing 20 that is positioned on the proximaltibial component 22. The proximal tibial component 22 is affixed to theproximal end of the tibia 18. The tibial bearing 20 has a contouredproximal surface 24, against which the condyles 26 of the distal femoralcomponent 28 bear. The distal femoral component 28 is affixed to thedistal end of the femur 16. Articulation of the joint is at theinterface of the proximal surface 24 of the tibial bearing 20 and thecondyles 26 of the distal femoral component 28.

The actual use of the knee endoprosthesis system 14 may be characterizedas cycles of use of the system. The cycles of use of the system 14 maybe measured in a variety of methods such as, for example, (i) bydetermining number of steps taken by the patient, (ii) by determiningthe activity level of the patient, (iii) by determining the number oftimes a predetermined joint flexion angle is achieved by the system 14,or (iv) by determining the number of loading cycles of the system 14.

In the exemplary embodiment shown in FIG. 1, the joint use measurementdevice 10 is embodied as a pedometer 30. The pedometer 30 is worn by thepatient subsequent to the patient's orthopaedic procedure to determinethe number of steps taken by the patient. When the output from thepedometer 30 indicates that the patient has taken a predetermined numberof steps since the patient's orthopaedic procedure (or since thepatient's previous meeting with the surgeon), a communication with theorthopaedic surgeon may be initiated. For example, the patient may makean appointment with the surgeon's office via telephone, electronic mailor other web-based communication, conventional mail, etcetera.

Referring now to FIG. 2, there is shown an arrangement similar to FIG.1, but showing the joint use measurement device 10 embodied as anelectronic body monitor 32. The electronic body monitor 32 is configuredto be worn externally of the patient's body such as, for example, on anarmband. Like the pedometer 30 of FIG. 1, the electronic body monitor 32may be used to determine the number of steps taken by the patient over agiven period of time (e.g., since the patient's procedure or since thepatient's previous post-surgical meeting with the surgeon). Theelectronic body monitor 32 may also execute algorithms for determiningand tracking the activity level of the patient. In this way, follow-upmay be initiated as a function of steps taken by the patient, activitylevel of the patient, or both.

As shown in FIG. 2, the electronic body monitor 32 includes a sensor 34that is configured to sense parameters associated with cycles of use ofthe knee endoprosthesis system 14. The sensor 34 may be embodied as asingle sensor or as an array of sensors. In one exemplary embodiment,the sensor 34 is embodied as a two-axis accelerometer the output fromwhich may be used to determine the number of steps taken by the patient.The electronic body monitor 32 also includes a processor 36 electricallycoupled to the sensor 34, a memory device 38, and a data output port 40.The processor 36 is electrically coupled to the data output port 40 andthe memory device 38. The electronic body monitor 32 may also includeother devices useful in a computing device such as drivers, registers,buffers, digital signal processors, and the like. Illustratively, theelectronic body monitor 32 may be embodied, with or without modificationthereto, as any one of the numerous body monitors commercially availablefrom BodyMedia, Incorporated of Pittsburgh, Pa. One such BodyMediadevice is commercially sold under the name SenseWare PRO.

The processor 36 and memory device 38 cooperate to determine whenfollow-up subsequent to an orthopaedic procedure is warranted based oncycles of use of the knee endoprosthesis system 14. In particular, thememory device 38 has stored therein a plurality of instructions in theform of a software routine which performs such a function. The memorydevice 38 may be Random Access Memory (hereinafter sometimes RAM), ReadOnly Memory (hereinafter sometimes ROM), flash or erasable memory suchas Erasable Programmable ROM (hereinafter sometimes EPROM) andElectrically Erasable Programmable ROM (hereinafter sometimes EEPROM),and/or other memory devices. Due to the adaptable nature of programminglanguages, there are many embodiments of a software routine stored inthe memory device 38 for performing such a function.

The electronic body monitor 32 also includes a message generating device42. The message generating device 42 is operable to generate visualand/or audible messages for presentation to the patient. For example,when the electronic body monitor 32 determines that the patient hasexceeded a predetermined threshold relating to the number of steps takenby the patient (or activity level) since the patient's procedure (orlast meeting with the surgeon), an audible and/or visual alert may begenerated by the message generating device 42. The message generatingdevice 42 may be embodied as any type of such device including, forexample, an LCD or LED display and/or a tone/sound generator.

Referring now to FIG. 3, the joint use measurement device 10 includes animplanted sensor 50. The sensor 50 may be embodied as a single sensor oras an array of sensors. In the exemplary embodiment of FIG. 3, theimplanted sensor 50 includes a signal source 52, such as a permanentmagnet, that is embedded in the distal femoral component 28, and asensor 54, such as a Hall effect switch, embedded in the proximal tibialcomponent 22. The associated electronics 56 are also secured to theproximal tibial component 22. The electronics 56 include, amongst otherthings, a processor, memory device, power source, modulator, atransmitter, and antenna to facilitate the maintenance of a runningcount of the number of times the knee endoprosthesis system 14 cycles,along with the ability to transmit such a count from within thepatient's body. In other words, the joint use measurement device 10illustrated in FIG. 3 utilizes an implanted sensor to determine thenumber of occasions in which the components of the knee endoprosthesissystem 14 are in a predetermined relative position with one another(e.g., the number of occasions in which a predetermined flexion angle isattained), thereby determining cycles of use of the system 14.

The stored count information can be transmitted to a device external tothe patient's body by use of the transmitter and antenna of theassociated electronics 56. As shown schematically in FIG. 3, an externalreceiver 58 and data interpretation device 60 may be used to retrieveinformation from the implanted electronics 56. The external receiver 58may be embodied as a radio-frequency antenna that is operable to receivethe signal from the internal antenna of the implanted electronics 56.The data interpretation device 60 is electrically coupled to thereceiver 58, and may be embodied as a standard computer (e.g., PC)programmed to demodulate the radio-frequency signal received from theinternal transmitter and the internal antenna of the implantedelectronics 56. The data interpretation device 60 may also be embodiedas a hand-held personal computer, a personal desk assistant, a laptopcomputer, or any custom-designed data acquisition device. The datainterpretation device 60 may be programmed to perform calculationsnecessary to convert the received and demodulated signal into the numberof cycles recorded by the counter.

One such implantable system, along with the associated externalcomponents, is disclosed in U.S. patent application Ser. No. 10/887,766,entitled “In Vivo Joint Implant Cycle Counter” which is assigned to theassignee of the present application, and which is hereby incorporated byreference.

The data interpretation device 60 may have integrated therein, or becoupled to, a message generating device 62. The message generatingdevice 62 is operable to generate visual and/or audible messages forpresentation to the patient. For example, when it is determined from theoutput of the implanted electronics 56 that the number of occasions inwhich the knee endoprosthesis system 14 has attained a predeterminedflexion angle has exceeded a predetermined threshold, an audible and/orvisual alert may be generated by the message generating device 62. Themessage generating device 62 may be embodied as any type of such deviceincluding, for example, a PC display monitor, an LCD or LED display,and/or a tone/sound generator.

In lieu of the arrangement of FIG. 3 which includes a magnet and Halleffect switch, other implanted sensor arrangements are alsocontemplated. For example, a load sensor may be implanted into the kneeendoprosthesis system 14. In such a system, the cycles of use of thesystem 14 could be determined by counting loading cycles of the system.Such a count could be stored, transmitted, and received in a similarmanner to as described above in regard to the arrangement of FIG. 3.

In another example, the cycles of use of the patient's joint may bedetermined by measuring the wear of certain components of the kneeendoprosthesis system 14. For instance, a sensor arrangement may beutilized in which the joint space between the femoral component 28 andthe tibial component 22 is measured/monitored. It should be appreciatedthat such a distance may shorten (i.e., reduce) over cycles of the kneeendoprosthesis system as a result of wear of the tibial bearing 20. Assuch, the cycles of use of the system 14 could be determined bymeasuring and tracking the joint space between the femoral component 28and the tibial component 22. Such data could be stored, transmitted, andreceived in a similar manner to as described above in regard to thearrangement of FIG. 3. One such implantable system, along with theassociated external components, is disclosed in U.S. patent applicationSer. No. 10/888,243, entitled “System and Method for Determining PatientFollow-Up Subsequent to an Orthopaedic Procedure” which is assigned tothe assignee of the present application, and which is herebyincorporated by reference.

Referring now to FIG. 4, there is shown the joint use measurement device10 being used in conjunction with a communications device 70. Thecommunications device 70 may be embodied as hardware and software thatis integrated into a personal computer, wireless (e.g., cellular)telephone, PDA, or home automation system. Alternatively, thecommunications device 70 may be a discreet hardware/software assemblyelectrically coupled to a personal computer, wireless (e.g., cellular)telephone, PDA, or home automation system. In either case, thecommunications device 70 includes devices useful in a computing devicesuch as microprocessor(s), memory devices, drivers, registers, buffers,digital signal processors, and the like

The communications device 70 may be operated to query the joint usemeasurement device 10 and then commence an automated, device-initiatedcommunication with the orthopaedic care provider (e.g., the surgeon'soffice) if a follow-up visit is warranted based on the number of cyclesof use of the knee endoprosthesis system 14. For example, thecommunications device 70 may initiate a telephone call, electronic mailcommunication, or other web-based communication with an electronicdevice or system 72 operated by the surgeon's office.

It should be appreciated that the communications device 70 may beconfigured to accommodate any one or more of the different exemplaryembodiments of the joint use measurement device 10. For example, in thecase of the electronic body monitor 32 of FIG. 2, the communicationsdevice 70 may be configured to communicate with the body monitor 32 viaits data output port 40. Such a communication may be wired or wirelessdepending on the configuration of the port 40. It is contemplated tointegrate the communications device 70 into the electronic body monitor32.

Similarly, the communications device 70 may be configured to communicatewith data interpretation device 60 of the arrangement of FIG. 3 viaeither a wired or wireless communication link. It should be appreciatedthat the communications device 70 may be integrated into the datainterpretation device 60 (i.e., a single device, such as a PC, may beequipped with the necessary hardware and software to perform both thefunctions of the data interpretation device 60 and the functions of thecommunications device 70).

In the case of when the joint use measurement device 10 is embodied as amechanical device (i.e., non-electrical) such as, for example, certaintypes of pedometers, data from the mechanical device may be input intothe communications device 70. In such a case, the communications device70 may be configured to process such manually entered data, and then, ifappropriate, initiate communication with the surgeon in any one or moreof the manners described above.

Although the concepts of the present disclosure have herein beendescribed in regard to a knee prosthesis, it should be appreciated thatthe concepts described herein could also be applied to other jointendoprosthesis such as endoprosthesis systems for use in the hip,shoulder, wrist, elbow, ankle, along with endoprosthesis systems for usewith the digits of the extremities. It should be understood that otherconfigurations of a joint use measurement device (including its sensors)may be utilized to accommodate a given application in a desired jointlocation.

Moreover, although the concepts of the present disclosure have hereinbeen exemplary described in regard to an endoprosthesis for use in atotal joint replacement, it should be appreciated that the conceptsdescribed herein could also be applied to other arrangements. Forexample, the concepts of the present disclosure could be appliedsubsequent to a procedure in which the resultant joint includes one ormore natural components. Moreover, the concepts of the presentdisclosure could be applied subsequent to an orthopaedic procedure atanatomical locations other than a joint.

While the disclosure is susceptible to various modifications andalternative forms, specific exemplary embodiments thereof have beenshown by way of example in the drawings and has herein be described indetail. It should be understood, however, that there is no intent tolimit the disclosure to the particular forms disclosed, but on thecontrary, the intention is to cover all modifications, equivalents, andalternatives falling within the spirit and scope of the disclosure.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus and methods described herein.It will be noted that alternative embodiments of the apparatus andmethods of the present disclosure may not include all of the featuresdescribed yet still benefit from at least some of the advantages of suchfeatures. Those of ordinary skill in the art may readily devise theirown implementations of an apparatus and method that incorporate one ormore of the features of the present disclosure and fall within thespirit and scope of the present disclosure.

The invention claimed is:
 1. A system for monitoring a patient's use ofan orthopaedic joint which includes first and second joint prosthesiscomponents, comprising: an implantable sensor which, when implanted in apatient, can be used to monitor the number of cycles of use of theorthopaedic joint, a processor in communication with the sensor, and amemory device electrically coupled to the processor, the memory devicehaving stored therein a plurality of instructions which, when executedby the processor, cause the processor to (i) monitor output from thesensor to determine the number of cycles of use of the orthopaedicjoint, and (ii) to generate a message to the patient indicative of aneed to initiate communication with an orthopaedic care provider if thenumber of cycles of use of the orthopaedic joint exceeds a predeterminethreshold value, wherein the implantable sensor comprises a permanentmagnet embedded in the first joint prosthesis component and a Halleffect switch embedded in the second joint prosthesis component, thesystem further comprising electronics associated with the permanentmagnet and the Hall effect switch that are adapted to determine thenumber of occasions in which the first and second joint prosthesiscomponent are in a predetermined position relative to one another. 2.The system of claim 1, wherein the processor and the memory device areembedded in one of the first and second joint prostheses.
 3. The systemof claim 1, wherein the processor and the memory device are located in adata interpretation device separate from the orthopaedic joint.
 4. Thesystem of claim 3, wherein the electronics includes a transmitter totransmit data indicative of the number of occasions in which the firstand second joint prosthesis component are in the predetermined positionrelative to one another to the data interpretation device.
 5. The systemof claim 1, wherein the electronics are configured to determine thenumber of occasions in which a predetermined angle of flexion isattained by the orthopaedic joint.
 6. The system of claim 5, wherein thepredetermined angle of flexion is indicative of a step having been takenby the patient.
 7. The system of claim 1, wherein the message is atleast one of an audible message and a visual message.
 8. A system fordetermining patient follow-up subsequent to an orthopaedic procedure,the system comprising: an orthopaedic prosthesis comprising: a femoralcomponent having a signal source embedded therein; a tibial componenthaving an electrical circuit embedded therein, the electrical circuitcomprising a sensor to generate a data signal in response to the signalsource, the electrical circuit configured to (i) determine the number ofoccasions in which the femoral component and the tibial component are ina predetermined position relative to one another as a function of thedata signal, (ii) calculate a cycle count indicative of a cumulativenumber of cycles of use of the orthopaedic prosthesis, and (iii)transmit the cycle count; and a computing device configured to receivethe data signal and generate a message indicating a need to initiatecommunication with an orthopaedic care provider in response to the cyclecount exceeding a reference threshold value.
 9. The system of claim 8,wherein the signal source is a permanent magnet and the sensor is a Halleffect switch.
 10. The system of claim 8, wherein the computing deviceincludes a display and the message comprises a visual message displayedon the display of the computing device.
 11. The system of claim 8,wherein the computing device is further configured initiate acommunication with the orthopaedic care provider in response to thecycle count exceeding the reference threshold value.
 12. The system ofclaim 11, wherein the computing device is configured to generate ane-mail to the orthopaedic care provider.
 13. The system of claim 11,wherein the computing device is configured to initiate a telephone callto an office of the orthopaedic care provider.
 14. The system of claim11, wherein the computing device comprises: communication circuitry; adisplay; a processor; and memory having stored therein a plurality ofinstructions that, in response to the processor, cause the processor to:generate a visual message to the patient to the patient on the displaythat indicates a need to initiate communication with the orthopaediccare provider in response to the cycle count exceeding the referencethreshold value, and initiate a communication with the orthopaedic careprovider in response to the cycle count exceeding the referencethreshold value.